Research Compliance & Quality Assurance (RCQA)

Mission

To reinforce the Compliance Program at the University of Miami by promoting and sustaining the highest quality clinical research, with the goal of protecting human subjects and maintaining research integrity. To reach this goal our office promotes continuous quality improvement by offering audits of clinical research, clinical trial disclosure support, CAPA management, CAPA follow-up and educational seminars.

Services

The offices support and help clinical and translational investigators to comply with national and international regulations and guidelines from the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), International Conference on Harmonisation-Good Clinical Practice (ICH-GCP), European Medicines Agency (EMA), as well as state laws and local policies and procedures.

RCQA provides the following services:

  1. Audits
  2. Voluntary assessments
  3. Preparation of Principal Investigators (PIs) and study teams for external federal audits
  4. Assistance for PIs and study teams during external federal audits
  5. Assistance with responses to federal agencies (Form FDA 483, EMA audit reports, NIH audit reports, etc.)
  6. Corrective And Preventive Action (CAPA) system
  7. Clinical Trial Disclosure Compliance System
  8. Research related education and training

University of Miami is registered with ClinicalTrials.gov. For assistance with protocol registration and results reporting, contact the Protocol Registration Administrator (PRS) Yolanda Davis y.p.davis@med.miami.edu and include CT.gov in the subject line.

Contact

Meet the team:

Johanna Stamates
Executive Director
Phone: (305) 243-4538
Email: jstamates@med.miami.edu

Helen Miletic
QA Manager
Phone: (305) 243-4306
Email: hmiletic@med.miami.edu

Nelson Vega
QA Auditor
Phone: (305) 243-7797
Email: n.vega1@med.miami.edu

Emil Kamar
QA Auditor
Phone: (305) 243-4994
Email: e.kamar@med.miami.edu

Luis Rochel
CAPA Manager
Phone: (305) 243-0135
Email: lrochel@med.miami.edu

Yolanda Davis
Clinical Trials Disclosure Manager
Phone: (305) 243-0494
Email: y.p.davis@med.miami.edu

Patty Hitchcock Tate
Sr. Administrative Assistant
Phone: (305) 243-9740
Email: plt18@miami.edu

Helpful links from the University
Helpful links from outside the University

Upcoming Events

2016 FDA/UM Conference. “Improving Clinical Research in the Age of Precision Medicine”
REGISTRATION

The Seminar will take place on Wednesday, September 14 and Thursday, September 15, 2016, from 8:00 AM – 5:00 PM at The University of Miami Bank United Center located at 1245 Dauer Drive, Coral Gables, FL 33146. The cost of registration for the two-day seminar is $175.00 (breakfast, lunch and refreshments for both days are included in the registration fee) Last day to purchase tickets is September 9, 2016. Seats are limited.

  • Registration Information
    • Event Contact: Johanna Stamates JStamates@med.miami.edu 305-243-4215 or
      Patty Tate plt18@miami.edu 305-243-9740
    • Cancellation Policy: Cancellations received by August 30, 2016 are refundable, minus a $10 registration service charge. After that, cancellations are subject to the entire conference fee. Please note that if you cancel and do not attend, payment is not refundable. Substitutions may be made up until September 9, 2016.
    • Privacy Policy: http://www.miami.edu/index.php/privacy_statement/

21st Annual BioEthics Conference click link for information UM_Bioethics_Brochure_3_2016.pdf

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